Modular combination of medication infusion and analyte monitoring

ABSTRACT

Methods and systems for providing modular components in an integrated infusion device and analyte monitoring system where the components are independently repleaceable are provided.

RELATED APPLICATION

The present application claims priority to U.S. application Ser. No.12/032,593 filed Feb. 15, 2008 (issued as U.S. Pat. No. 9,636,450),which claims priority under 35 U.S.C. 119(e) to U.S. provisional patentapplication No. 60/890,497 filed Feb. 19, 2007, entitled “ModularCombination of Medication Infusion And Analyte Monitoring”, and assignedto the Assignee of the present application, Abbott Diabetes Care, Inc.of Alameda, Calif., the disclosure of which in incorporation herein byreference for all purposes.

FIELD OF THE INVENTION

The present disclosure related to methods and systems for integratinginfusion systems and analyte monitoring systems. More specifically, thepresent disclosure related to methods and systems for providing modularcombination for integrated infusion and analyte monitoring systems.

BACKGROUND

Type 1 diabetes must periodically be administered with insulin tosustain their physiological conditions. Typically, these patentsadminister doses of either fast acting or slow acting insulin usingneedle type syringes, for example, prior to meals, and/or at a suitabletime during the course of each day contemporaneously with the bloodglucose level testing using fingerstick testing, for example. If insulinis not suitable administered, the diabetic patients risk serious if notfatal damage to the body.

Continued development and improvement in the external infusion pumptherapy in recent years have drawn much appeal to the diabetic patientsfor, among others, improved management of diabetes by better regulatingand controlling the intake of insulin. Typically, the patient inserts acannula which is connected to an infusion tubing attached to an externalpump, and insulin is administered based on a preprogrammed basalprofiles. Moreover, the external infusion devices presently availableinclude computational capability to determine suitable bolus doses suchas carbohydrate bolus and correction bolus, for example, to beadministered in conjunction with the infusion device executing thepatient's basal profile.

The basal profiles are generally determined by the parent's physician orcaretaker and are based on a number of factors including the patient'sinsulin sensitivity and physiological condition which are diagnosed bythe patient's physician, for example, and are typically intended to asaccurately estimate the patient's glucose levels over a predeterminedtime period during which the patient is infusing insulin. The glucoselevels may be estimated based on the patient's periodic discrete testingusing a test strip and a blood glucose meter such as Freestyle® GlucoseMeter available from Abbott Diabetes Care, Inc., of Alameda, Calif. Suchestimations are, however, prone to error, and do not accurately mirrorthe patient's actual physiological condition.

Furthermore, each aspect of the infusion and the analyte monitoringrequire components that are configured to execute the associatedfunctions related to, for example, the control and management of insulindelivery and analyte monitoring. In addition, these components are proneto failure or otherwise periodic replacement due to ordinary usage. Inview of the foregoing, it would be desirable to have a modular systemincluding medication delivery unit such as an insulin pump, and ananalyte monitoring device such as a continuous glucose monitoringsystem, that would allow for component based replacement when one ormore aspects of the overall therapy management system fails or requiresreplacement.

SUMMARY

In accordance with the various embodiments of the present disclosure,there are provided method and system for modular combination ofmedication delivery and physiological condition monitoring.

These and other objects, features and advantages of the presentdisclosure will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an integrated infusion device and analyte monitoringsystem in accordance with one embodiment of the present disclosure;

FIG. 2 illustrates an integrated infusion device and analyte monitoringsystem in accordance with another embodiment of the present disclosure;

FIG. 3 illustrates an integrated infusion device and analyte monitoringsystem in accordance with yet another embodiment of the presentdisclosure;

FIG. 4 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still another embodiment of the presentdisclosure;

FIG. 5 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still a further embodiment of the presentdisclosure;

FIG. 6 illustrates an integrated infusion device and monitoring systemin accordance with yet still a further embodiment of the presentdisclosure;

FIG. 7 A illustrates the integrated infusion device and monitoringsystem shown in FIG. 6 in further detail in one embodiment of thepresent disclosure, while FIGS. 7B-7C illustrate the analog front endcircuitry located at the patient interface and the pump assembly,respectively, of the integrated infusion device and monitoring systemshown in FIG. 7A in accordance with one embodiment of the presentdisclosure;

FIGS. 8A-8C illustrate a passive sensor configuration for use in acontinuous analyte monitoring system, and two embodiments of an activesensor configuration for use at the patient interface in the integratedinfusion device and monitoring system, respectively, in accordance withone embodiment of the present disclosure;

FIG. 9 illustrates an integrated infusion device and analyte monitoringsystem with the infusion device and the monitoring system transmitterintegrated into a single patch worn by the patient in accordance withone embodiment of the present disclosure;

FIG. 10 is a detailed view of the infusion device cannula integratedwith analyte monitoring system sensor electrodes in accordance with oneembodiment of the present disclosure;

FIG. 11A illustrates a component perspective view of the infusion devicecannula integrated with analyte monitoring system sensor electrodes inaccordance with another embodiment of the present disclosure, while FIG.11B illustrates a top planar view of the analyte monitoring systemtransmitter unit integrated with infusion device in accordance with oneembodiment of the present disclosure;

FIG. 12A-12C each illustrate a cross sectional view of the infusiondevice cannula integrated with continuous analyte monitoring systemsensor electrodes of FIG. 10 in accordance with the various embodimentsrespectively, of the present disclosure;

FIG. 13 is a timing chart for illustrating the temporal spacing of bloodglucose measurement and insulin delivery by the migrated infusion deviceand monitoring system in one embodiment;

FIGS. 14A-14C illustrates modular combination of medication delivery andphysiological condition monitoring system in accordance with oneembodiment;

FIGS. 15A-15C illustrates modular combination of medication delivery andphysiological condition monitoring system in accordance with anotherembodiment;

FIG. 16 illustrates a top planar view of a modular sensor component inaccordance with one embodiment; and

FIG. 17 illustrates modular combination of medication delivery andphysiological condition monitoring system in accordance with yet anotherembodiment.

DETAILED DESCRIPTION

FIG. 1 illustrates an integrated infusion device and analyte monitoringsystem in accordance with one embodiment of the present disclosure.Referring to FIG. 1, the integrated infusion device and analytemonitoring system 100 in one embodiment of the present disclosureincludes an infusion device 110 connected to an infusion tubing 130 forliquid transport or infusion, and which is further coupled to a cannula170. As can be seen from FIG. 1, the cannula 170 is configured to bemountable coupled to a transmitter unit 150, where the transmitter unit150 is also mountable coupled to an analyte sensor 160. Also provided isan analyte monitor unit 120 which is configured to wirelesslycommunicate with the transmitter unit over a communication path 140.

Referring to FIG. 1, in one embodiment of the present disclosure, thetransmitter unit 150 is configured for unidirectional wirelesscommunication over the communication path 140 to the analyte monitorunit 120. In one embodiment, the analyte monitor unit 120 may beconfigured to include a transceiver unit (not shown) for bidirectionalcommunication over the communication path 140. The transmitter unit 150in one embodiment may be configured to periodically or continuouslytransmit signals associated with analyte levels defected by the analytesensor 160 to the analyte monitor unit 120. The analyte monitor unit 120may be configured to receive the signals from the transmitter unit 150and in one embodiment, is configured to perform data storage andprocessing based on one or more preprogrammed or predeterminedprocesses.

For example, in one embodiment, the analyte monitor unit 120 isconfigured to store the received signals associated with analyte levelsin a data storage unit (not shown). Alternatively, or in addition, theanalyte monitor unit 120 may be configured to process the signalsassociated with the analyte levels to generate trend indication by, forexample, visual display of a line chart or an angular icon based displayfor output display on its display unit 121. Additional information maybe output displayed on the display unit 121 of the analyte monitor unit120 including, but not limited to, the substantially contemporaneous andmonitored real time analyte level of the patient received from thetransmitter unit 150 as detected by the sensor 160. The real timemonitored analyte level may be displayed in a numeric format or in anyother suitable format which provides the patient with the accuratemeasurement of the substantially real time analyte level detected by thesensor 160.

Analytes that may be monitored or determined by the sensor 160 include,for example, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones,lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroidstimulating hormone, and troponin. The concentration of drugs, such as,for example, antibiotics (e.g., gentamicin, vancomycin, and the like),digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may alsobe determined.

Referring back to FIG. 1, the sensor 160 may include a short term (forexample, 3 day, 5 day or 7 day use) analyte sensor which is replacedafter its intended useful life. Moreover, in one embodiment, the sensor100 is configured to be positioned subcutaneous to the skin of thepatient such that at least a portion of the analyte sensor is maintainedin fluid contact with the patient's analyte such as, for example,interstitial fluid or blood. In addition, the cannula 170 which isconfigured to similarly be positioned under the patient's skin isconnected to the infusion tubing 130 of the infusion device 110 so as todeliver medication such as insulin to the patient. Moreover, in oneembodiment, the cannula 170 is configured to be replaced with thereplacement of the sensor 160.

In one aspect of the present disclosure, the cannula 170 and the sensor160 may be configured to be subcutaneously positioned under the skin ofthe patient using an insertion mechanism (not shown) such as aninsertion gun which may include, for example, a spring biased or loadedinsertion mechanism to substantially accurately position the cannula 170and the sensor 160 under the patient's skin. In this manner, the cannula170 and the sensor 160 may be subcutaneously positioned withsubstantially little or no perceived pain by the patient. Alternatively,the cannula 170 and/or the sensor 160 may be configured to be manuallyinserted by the patient through the patient's skin. After positioningthe cannula 170 and the sensor 160, they may be substantially firmlyretained in position by an adhesive layer 180 which is configured toadhere to the skin of the patient for the duration of the time periodduring which the sensor 160 and the cannula 170 are subcutaneouslypositioned.

Moreover, in one embodiment, the transmitter unit 150 may be mountedafter the subcutaneous positioning of the sensor 160 and the cannula 150so as to be in electrical contact with the sensor electrodes. Similarly,the infusion tubing 130 may be configured to operatively couple to thehousing of the transmitter unit 150 so as to be accurately positionedfor alignment with the cannula 170 and to provide a substantially watertight seal. Exemplary analyte systems that may be employed are describedin, for example, U.S. Pat. Nos. 6,134,461, 6,175,752, 6,121,611,6,560,471, 6,746,582, and elsewhere.

Referring back to FIG. 1, the infusion device 110 may includecapabilities to program basal profiles, calculation of bolus dosesincluding, but not limited to correction bolus, carbohydrate bolus,extended bolus, and dual bolus, which may be performed by the patientusing the infusion device 110, and may be based on one or more factorsincluding the patient's insulin sensitivity, insulin on board, intendedcarbohydrate intake (for example, for the carbohydrate bolus calculationprior to a meal), the patient's measured or detected glucose level, andthe patient's glucose trend information. In a further embodiment, thebolus calculation capabilities may also be provided in the analytemonitor unit 120.

In one embodiment, the analyte monitor unit 120 is configured with asubstantially compact housing that can be easily carried by the patient.In addition, the infusion device 110 similarly may be configured as asubstantially compact device which can be easily and conveniently wornon the patient's clothing (for example, housed in a holster or acarrying device worn or clipped to the patient's belt or other parts ofthe clothing). Referring yet again to FIG. 1, the analyte monitor unit120 and/or the infusion device 110 may include a user interface such asinformation input mechanism by the patient as well as data outputincluding, for example, the display unit 121 on the analyte monitor unit120, or similarly a display unit 111 on the infusion device 110.

One or more audio output devices such as, for example, speakers orbuzzers may be integrated with the housing of the infusion device 110and/or the analyte monitor unit 120 so as to output audible alerts oralarms based on the occurrence of one or more predetermined conditionsassociated with the infusion device 110 or the analyte monitor unit 120.For example, the infusion device 110 may be configured to output anaudible alarm or alert to the patient upon detection of an occlusion inthe infusion tubing 130 or the occurrence of a timed event such as areminder to prime the infusion tubing upon replacement of the cannula170, and the like.

The analyte monitor unit 120 may be similarly configured to output anaudible alarm or alert when a predetermined condition or apre-programmed event occurs, such as, for example, a reminder to replacethe sensor 160 after its useful life (of, for example, 3 days, 5 days or7 days, or more), or one or more alerts associated with the datareceived from the transmitter unit 150 corresponding to the patient'smonitored analyte levels. Such alerts or alarms may include a warningalert to the patient that the detected analyte level is beyond apredetermined threshold level, or the trend of the detected analytelevels within a given time period is indicative of a significantcondition such as potential hyperglycemia or hypoglycemia, which requireattention or corrective action. It is to be noted that the examples ofaudible alarms and/or alerts are described above for illustrativepurposed only, that within the scope of the present disclosure, otherevents or conditions may be programmed into the infusion device 110 orthe analyte monitor unit 120 or both, so as to alert or notify thepatient of the occurrence or the potential occurrence of such events orconditions.

In addition, within the scope of the present disclosure, audible alarmsmay be output alone, or in combination with one or more of a visualalert such as an output display on the display unit 111, 121 of theinfusion device 110 or the analyte monitor unit 120, respectively, orvibratory alert which would provide a tactile indication to the patientof the associated alarm and/or alert.

Moreover, referring yet again to FIG. 1, while one analyte monitor unit120 and one transmitter unit 150 are shown, within the scope of thepresent disclosure, additional analyte monitor units or transmitterunits may be provided such that, for example, the transmitter unit 150may be configured to transmit to multiple analyte monitor unitssubstantially simultaneously. Alternatively, multiple transmitter unitscoupled to multiple sensors concurrently in fluid contact with thepatient's analyte may be configured to transmit to the analyte monitorunit 120, or to multiple analyte monitor units. For example, anadditional transmitter unit coupled to an additional sensor may beprovided in the integrated infusion device and analyte monitoring system100 which does not include the cannula 170, and which may be used toperform functions associated with the sensor 160 such as sensorcalibration, sensor data verification, and the like.

In one embodiment, the transmitter unit 150 is configured to transmitthe sampled data signals received from the sensor 160 withoutacknowledgement from the analyte monitor unit 120 that the transmittedsampled data signals have been received. For example, the transmitterunit 150 may be configured to transmit the encoded sampled data signalsat a fixed rate (e.g., at one minute intervals, or any suitable rate)after the completion of the initial power on procedure. Likewise, theanalyte monitor unit 120 may be configured to detect such transmittedencoded sampled data signals at predetermined time intervals.Alternatively, the transmitter unit 150 and the analyte monitor unit 120may be configured for bi-directional communication over thecommunication path 140.

Additionally, in one aspect, the analyte monitor unit 120 may includetwo sections. The first section of the analyte monitor unit 120 mayinclude an analog interface section that is configured to communicatewith the transmitter unit 150 via the communication path 140. In oneembodiment, the analog interface section may include an RF receiver andan antenna for receiving and amplifying the data signals from thetransmitter unit 150, which are thereafter, demodulated with a localoscillator and filtered through a band-pass filter. The second sectionof the analyte monitor unit 120 may include a data processing sectionwhich is configured to process the data signals received from thetransmitter unit 150 such as by performing data decoding, errordetection and correction, data clock generation, and data bit recovery,for example.

In operation, upon completing the power-on procedure, the analytemonitor unit 120 is configured to detect the presence of the transmitterunit 150 within its range based on, for example, the strength of thedetected data signals received from the transmitter unit 150 orpredetermined transmitter identification information. Upon successfulsynchronization with the transmitter unit 150, the analyte monitor unit120 is configured to begin receiving from the transmitter unit 150 datasignals corresponding to the patient's detected analyte, for exampleglucose, levels.

Referring again to FIG. 1, the analyte monitor unit 120 or the infusiondevice 110, or both may be configured to further communicate with a dataprocessing terminal (not shown) which may include a desktop computerterminal, a data communication enabled kiosk, a laptop computer, ahandheld computing device such as a personal digital assistant (PDAs),or a data communication enable mobile telephone, and the like, each ofwhich may be configure for data communication via a wired or a wirelessconnection. The data processing terminal for example may includephysician's terminal and/or a bedside terminal in a hospitalenvironment.

The communication path 140 for data communication between thetransmitter unit 150 and the analyte monitor unit 120 of FIG. 1 mayinclude an RF communication link, Bluetooth communication link, infraredcommunication link, or any other type of suitable wireless communicationconnection between two or more electronic devices. The datacommunication link may also include a wired cable connection such as,for example, but not limited to an RS232 connection, USB connection, orserial cable connection.

Referring yet again to FIG. 1, in a further aspect of the presentdisclosure, the analyte monitor unit 120 or the infusion device 110 (orboth) may also include a test strip port configured to receive a bloodglucose test strip for discrete sampling of the patient's blood forglucose level determination. An example of the functionality of bloodglucose test strip meter unit may be found in Freestyle® Blood GlucoseMeter available from the assignee of the present disclosure, AbbottDiabetes Care, Inc.

In the manner described above, in one embodiment of the presentdisclosure, the cannula 170 for infusing insulin or other suitablemedication is integrated with the adhesive patch 180 for the sensor 160and the transmitter unit 150 of the analyte monitoring system.Accordingly, only one on-skin patch can be worn by the patient (forexample, on the skin of the abdomen) rather than two separate patchesfor the infusion device cannula 170, and the analyte monitoring systemsensor 160 (with the transmitter unit 150). Thus, the Type-1 diabeticpatient may conveniently implement infusion therapy in conjunction withreal time glucose monitoring while minimizing potential skin irritationon the adhesive patch 180 site on the patient's skin, and thus providemore insertion sites with less irritation.

In addition, the integrated infusion device and analyte monitoringsystem 100 as shown in FIG. 1 may be configured such that the infusiontubing 130 may be disconnected from the infusion device 110 as well asfrom the housing of the transmitter 150 (or the adhesive patch 180) suchthat, optionally, the patient may configure the system as continuousanalyte monitoring system while disabling the infusion device 110functionality. Likewise, a patient may configure the system as aninfusion device while disabling the continuous analyte monitoring systemfunctions.

Moreover, in accordance with one embodiment of the present disclosure,the patient may better manage the physiological conditions associatedwith diabetes by having substantially continuous real time glucose data,trend information based on the substantially continuous real timeglucose data, and accordingly, modify or adjust the infusion levelsdelivered by the infusion device 110 from the pre-programmed basalprofiles that the infusion device 110 is configured to implement.

FIG. 2 illustrates an integrated infusion device and analyte monitoringsystem in accordance with another embodiment of the present disclosure.Referring to FIG. 2, the integrated infusion device and analytemonitoring system 200 in one embodiment of the present disclosureincludes an integrated infusion device and analyte monitor unit 210which is coupled to an infusion tubing 220 connected to the cannula 260.Also shown in FIG. 2 is a transmitter unit 240 which is in electricalcontact with an analyte sensor 250, where the cannula 260 and theanalyte sensor 250 are subcutaneously postitioned under the skin of thepatient, and retained in position by an adhesive layer or patch 270.

Referring to FIG. 2, the integrated infusion device and analyte monitorunit 210 is configured to wirelessly communicate with the transmitterunit 240 over a communicatin path 230 such as an RF communication link.Compared with the embodiment shown in FIG. 1, it can be seen that in theembodiment shown in FIG. 2, the infusion device and the analyte monitorare integrated into a single housing 210. In this manner, thetransmitter unit 240 may be configure to transmit signals correspondingto the detected analyte levels received from the analyte sensor 250 tothe integrated infusion device and analyte monitor 210 for data analysisand processing.

Accordingly, the patient may conveniently receive real time glucoselevels from the transmitter unit 240 and accordingly, determine whetherto modify the existing basal profile(s) in accordance with which insulinis delivered to the patient. In this manner, the functionalities of theanalyte monitor unit may be integrated within the compact housing of theinfusion device to provide additional convenience to the patient, forexample, by providing the real time glucose data as well as otherrelevant information such as glucose trend data to the user interface ofthe infusion device, so that the patient may readily and easilydetermine any suitable modification to the infusion rate of the insulinpump.

In one embodiment, the configurations of each component shown in FIG. 2including the cannula 260, the analyte sensor 250, the transmitter unit240, the adhesive layer 270, the communication path 230, as well as theinfusion tubing 220 and the functionalities of the infusion device andthe analyte monitor are substantially similar to the correspondingrespective component as described above in conjunction with FIG. 1.

Accordingly, in one embodiment of the present disclosure, the additionalconvenience may be provided to the patient in maintaining and enhancingdiabetes management by, for example, having a single integrated devicesuch as the integrated infusion device and analyte monitor unit 210which would allow the patient to easily manipulate and manage insulintherapy using a single user interface system of the integrated infusiondevice and analyte monitor unit 210. Indeed, by providing theinformation associated with both the glucose levels and insulin infusionin a single device, the patient may be provided with the additionalconvenience in managing diabetes and improving insulin therapy.

FIG. 3 illustrates as integrated infusion device and analyte monitoringsystem in accordance with yet another embodiment of the presentdisclosure. Referring to FIG. 3, the integrated infusion device andanalyte monitoring system 300 in one embodiment of the presentdisclosure includes an infusion device 310 connected to an infusiontubing 340 coupled to a cannula 370. The cannula 370 is configured to bepositioned subcutaneously under the patient's skin and substantiallyretained in position by an adhesive layer 380. Also retained inposition, as discussed above and similar to the embodiments described inconjunction with FIGS. 1-2, is an analyte sensor 360 also positionedsubcutaneously under the patient's skin and maintained in fluid contactwith the patient's analyte. A transmitter unit 350 is provided so as tobe electrically coupled to the analyte sensor 360 electrodes. Also, ascan be seen from FIG 3, in one embodiment, the infusion tubing 340 isconnected to the housing of the transmitter unit 350 so as to connect tothe cannula 370 disposed under the patient's skin.

Referring to FIG. 3, also provided is an analyte monitor unit 320configured to wirelessly communicate with the transmitter unit 350 toreceive data therefrom associated with the analyte levels of the patientdetected by the analyte sensor 360. Referring to FIG. 3, in oneembodiment the infusion device 310 does not include a user interfacesuch as a display unit and/or an input unit such as buttons or a jogdial. Instead, the user interface and control mechanism is provided onthe analyte monitoring unit 320 such that the analyte monitoring unit320 is configured to wirelessly control the operation of the infusiondevice 310 and further, to suitably program the infusion device 310 toexecute pre-programmed basal profile(s), and to otherwise control thefunctionality of the infusion device 310.

More specifically, all of the programming and control mechanism for theinfusion device 310 is provided in the analyte monitoring unit 320 suchthat when the patient is wearing the infusion device 310, it may be worndiscreetly under clothing near the infusion site on the patient's skin(such as abdomen), while still providing convenient access to thepatient for controlling the infusion device 310 through the analytemonitoring unit 320.

In addition, in one embodiment, the configurations of each componentshown in FIG. 3 including the cannula 370, the analyte sensor 360, thetransmitter unit 350, the adhesive layer 380, the communication path320, as well as the infusion tubing 340 and the functionalities of theinfusion device and the analyte monitoring unit 320 are substantiallysimilar to the corresponding respective component as described above inconjunction with FIG. 1. However, the infusion device 30 in theembodiment shown in FIG. 3 is configured with a transceiver or anequivalent communication mechanism to communicate with the analytemonitoring unit 320.

In this manner, in one embodiment of the present disclosure,configuration of the infusion device 310 without a user interfaceprovides a smaller and lighter housing and configuration for theinfusion device 310 which would enhance the comfort in wearing and/orcarrying the infusion device 310 with the patient. Moreover, since thecontrol and programming functions of the infusion device 310 is providedon the analyte monitoring unit 320, the patient may conveniently programand/or control the functions and operations of the infusion device 310without being tethered to the infusion tubing 340 attached to thecannula 370 which is positioned under the patient's skin. In addition,since the programming and control of the infusion device 310 is remotelyperformed on the analyte monitoring unit 320, the infusion tubing 304may be shorter and thus less cumbersome.

FIG. 4 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still another embodiment of the presentdisclosure. Referring to FIG. 4, the integrated infusion device andanalyte monitoring system 400 in one embodiment of the presentdisclosure includes an infusion device 410 configured to wirelesslycommunicate with an analyte monitoring unit 420 over a communicationpath 430 such as an RF (radio frequency) link. In addition, as can befurther seen from FIG. 4, the infusion device 410 is connected to aninfusion tubing 440 which has provided therein integral wires connectedto the analyte sensor electrodes. As discussed in further detail below,the measure analyte levels of the patient is received by the infusiondevice 410 via the infusion tubing 440 and transmitted to the analytemonitoring unit 420 for further processing and analysis.

More specifically, referring to FIG. 4, the integrated infusion deviceand analyte monitoring system 400 includes a patch 450 provided with acannula 470 and an analyte sensor 460. The cannula 470 is configured todeliver or infuse medication such as insulin from the infusion device410 to the patient. That is, in one embodiment, the cannula 470 and theanalyte sensor 460 are configured to be positioned subcutaneous to thepatient's skin. The analyte sensor 460 is configured to be positioned tobe in fluid contact with the patient's analyte.

In this manner, the analyte sensor 460 is electrically coupled tointegral wires provided within the infusion tubing 440 so as to providesignals corresponding to the measured or detected analyte levels of thepatient to the infusion device 410. In one embodiment, the infusiondevice 410 is configured to perform date analysis and storage, such thatthe infusion device 410 may be configured to display the real timemeasured glucose levels to the patient on its display unit 411. Inaddition to or alternatively, the infusion device 410 is configured towirelessly transmit the received signals from the analyte sensor 460 tothe analyte monitoring unit 420 for data analysis, display, and/orstorage and the analyte monitoring unit 420 may be configured toremotely control the functions and features of the infusion device 410providing additional user convenience and discreteness.

Referring back to FIG. 4, in one embodiment, the patch 450 may beconfigured to be substantially small without a transmitter unit mountedthereon, and provided with a relatively small surface area to beattached to the patient's skin. In this manner, the pattern may beprovided with added comfort in having a substantially compact housingmounted on the skirt (attached with an adhesive layer, for example), toinfuse medication such as insulin, and for continuous analyte monitoringwith the analyte sensor 460.

FIG. 5 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still a further embodiment of the presentdisclosure. As compared with the embodiment shown in FIG. 4, theintegrated infusion device and analyte monitoring system 500 of FIG. 5includes an integrated infusion device and analyte monitoring unit 510.Accordingly, one user interface is provided to the user including thedisplay unit 511 and input buttons 512 provided on the housing of theintegrated infusion device and analyte monitoring unit 510. Also shownin FIG. 5 are infusion tubing 520 with integral wires disposed thereinand connected to an analyte sensor 540 electrodes in fluid contact withthe patient's analyte. Moreover, as can be seen from FIG. 5, an adhesivepatch 530 is provided to retain the subcutaneous position of a cannula550 and the analyte sensor 540 in the desired positions under thepatient's skin.

Optionally, the integrated infusion device and analyte monitoring unit510 may be provided with wireless or wired communication capability soto communicate with a remote terminal such as a physician's computerterminal over a wireless communication path such as RF communicationlink, or over a cable connection such as a USB connection, for example.Referring back to FIG. 5, in one embodiment of the present disclosure,the diabetic patient using an infusion therapy is provided with fewercomponents to handle or manipulate further simplifying insulin therapyand glucose level monitoring and management.

FIG. 6 illustrates an integrated infusion device and monitoring systemin accordance with yet still a further embodiment of the presentdisclosure. Referring to FIG. 6, the integrated infusion device andanalyte monitoring system 600 is provided with an infusion devicewithout a user interface, and configured to wirelessly communicate withan analyte monitoring unit 620 over a communication path 630 such as anRF link. The infusion device 610 which may be provided in a compacthousing since it does not incorporate the components associated with auser interface, is connected to an infusion tubing 640 having disposedtherein integral wires correspondingly connected to the electrodes ofanalyte sensor 660 in fluid contact with the patient's analyte. Inaddition, the compact adhesive patch 650 in one embodiment is configuredto retain cannula 670 and the analyte sensor 660 in the desired positionunder the skin of the patient.

Similar to the embodiment shown in FIG. 3, the analyte monitoring unit620 is configured to control and program the infusion device 610 overthe communication link 630. In this manner, the control and programmingfunctions of the infusion device 610 may be remotely performed by theanalyte monitoring unit 620, providing convenience to the patient.

FIG. 7A illustrates the integrated infusion device and monitoring systemshown in FIG. 6 in further detail in one embodiment of the presentdisclosure, while FIGS. 7A-7B illustrate the analog front end circuitrylocated at the patient interface and the pump assembly, respectively, ofthe integrated infusion device and monitoring system shown in FIG. 7A inaccordance with one embodiment of the present disclosure. Referring toFIG. 7A, an infusion device 710 connected to an infusion tubing 720 withintegral wires provided therein for connection to the electrodes of theanalyte sensor is shown. The infusion tubing 720 is further connected toan adhesive patch 730 which is configured to retain cannula 750 andanalyte sensor 740 in the desired subcutaneous portion under the skin ofthe patient.

Referring to FIG. 7A, in one embodiment of the present disclosure, theinfusion device 710 may be provided with a first analog front endcircuitry unit 711, while the adhesive patch may be provided with asecond analog front end circuitry unit 731. The integral wires from theanalyte sensor 740 is configured to extend from the infusion device 710to the adhesive layer 730 via the infusion tubing 720. Since the analytesensor 740 in one embodiment is a passive component, the signals on theworking electrode and the reference electrodes of the analyte sensorsare subject to noise given the high impendence of the electrodes and thelength of the integral wires (in excess of a few centimeters). The noisein turn may potentially adversely affect the signals on the working andreference electrodes which may distort the measured analyte levelsdetected by the analyte sensor 740.

Given the length of the integral wire which corresponds to the length ofthe infusion tubing 720, in one embodiment, the signals from the workingand reference electrodes may be converted to low impedance signals tominimize adverse impact from the noise. Accordingly, the infusion device710 may be provided with a first analog front end circuitry unit 711,while the adhesive patch 730 may be provided with a second analog frontend circuitry unit 731 as discussed in further detail below inconjunction with FIGS. 7B and 7C.

Referring now to FIG. 7B, the second analog front end circuitry unit 731disposed on the adhesive patch 730 on the patient's skin, in oneembodiment includes an a trans-impedance amplifier (current to voltageconverter or “I-to-V”) 731A configured to convert the working electrode(W) current to a voltage (Vw), and to provide a guard signal (G), and aservo segment 731B to drive the counter electrode (C) voltage (Ve) basedon the reference electrode (R) voltage. Also shown in FIG. 7B is aLow-Pass Filter (LPF) and gain stage 711A that follow each of the I-to-Vand servo stages, and which is configured in one embodiment to drive anA/D (Analog-to-Digital) converter unit 711C whose results are read by acontroller such as a central processing unit (CPU) 711D. The A/Dconverter unit 711C and the CPU 711D and other peripherals may becombined into a single integrated circuit (IC) known as amicrocontroller (μC) such as the MSP430 product line.

Referring now to FIG. 7C, in one embodiment, the second analog front endcircuitry unit 731 may be implemented by a pair of operationalamplifiers (731A and 731B), four resistors (R1, R2, R3, Rf), and abypass capacitor (Cb). the I-to-F stage using operational amplifier 731Ais generated by the action of the input current from the workingelectrode (W) flowing through the feedback resistor (Rf) and creating avoltage differential that is driven by the operational amplifier 731A asthe low impedance signal Vw. The offset for the Vw signal is establishedby the resistor divider comprised of R1, R2 and R3 which also createsthe voltage of the guard signal (G)—a signal that is at the samepotential or voltage as the working electrode (W).

The servo, using operational amplifier 731B, in one embodiment, drivesthe counter electrode (C) voltage to the sensor so that the referenceelectrode (R) is at the second value set by the resistor dividercomprised of resistors R1, R2 and R3. This maintains the workingelectrode (W) voltage above the reference electrode (R) by a set amountknow as the “Poise Voltage” (i.e 40 mV). The bypass capacitor (Cb) maybe a small, low equivalent series resistance (ESR) capacitor, such as a0.1 uF (100 nF) multi-layer ceramic (MLC) capacitor, that acts toprovide local energy and reduce noise on the circuit. The voltage sourcefor this circuit may be provided by the potential difference between V+and V− where, for example, V+ may be 5V and V− may be ground (GND) or V+may be +3V and V− may be −3V.

In one embodiment, the operational amplifiers 731A, 731B, may beacquired as a dual operational amplifier integrated circuit (IC) in asingle, small 8-pin, surface mount technology (SMT) package such as theOPA2349 in a SOT23-8 package (3 mm by 3 mm). Similar dual operationalamplifier products may be available in even smaller ball-grid array(BGA) packages and as bare die that may be mounted directly to thecircuit substrate, such as a printed circuit board (PCB) or flexcircuit, using techniques such as “flip-chip” and wire-bond.

In one aspect, the analyte sensor described above in conjunction withthe Figures may include one or more working electrodes and a referenceelectrode or a reference/counter electrode disposed on a substrate, andfurther, may optionally include a separate counter electrode. Indeed, inone aspect, the various electrodes of the sensor as well as thesubstrate and the dielectric layers may be provided in a stacked, sideby side, or layered configuration or construction. For example, in oneaspect, the sensor may include a substrate layer and a first conductinglayer such as a carbon trace deposed on at least a portion of thesubstrate layer, and which may comprise the working electrode. Alsoshown disposed on at least a portion of the first conducting layer is asensing layer.

A first insulation layer such as a first dielectric layer may bedisposed or stacked on at least a portion of the first conducting layer,and further, a second conducting layer such as another carbon trace maybe disposed or stacked on top of at least a portion of the firstinsulation layer (or dielectric layer). The second conducting layer maycomprise the reference electrode, and in one aspect, may include a layerof silver/silver chloride (Ag/AgCl).

Further, a second insulation layer such as a dielectric layer in oneembodiment may be disposed or stacked on at least a portion of thesecond conducting layer. Further, a third conducting layer which mayinclude carbon trace and that may comprise the counter electrode may bedisposed on at least a portion of the second insulation layer. Finally,a third insulation layer may be disposed or stacked on at least aportion of the third conducting layer. In this manner, the analytesensor may be configured in a stacked, side by side or layeredconstruction or configuration such that at least a portion of each ofthe conducting layers is separated by a respective insulation layer (forexample, a dielectric layer).

Additionally, within the scope of the present disclosure, some or all ofthe electrodes of the analyte sensor may be provided on the same side ofthe substrate in a stacked construction as described above, oralternatively, may be provided in a co-planar manner such that eachelectrode is disposed on the same plane on the substrate, however, witha dielectric material or insulation material disposed between theconducting layers/electrodes. Furthermore, in still another aspect, theone or more conducting layers such as the electrodes of the sensor maybe disposed on opposing sides of the substrate.

Referring again to the Figures, FIGS. 8A-8C illustrate a passive sensorconfiguration for use in a continuous analyte monitoring system, and twoembodiments of an active sensor configuration for use at the patientinterface in the integrated infusion device and monitoring system,respectively, in accordance with one embodiment of the presentdisclosure. Referring to FIG. 8A, analyte sensor 810 includes workingelectrode 811, a guard trace 812, a reference electrode 813, and acounter electrode 814. In one embodiment, the “tail” segment 815 of theanalyte sensor 810 is configured to be positioned subcutaneously underthe patient's skin so as to be in fluid contact with the patient.

Referring now to FIG. 8B, analyte sensor 820 is provided with the analogfront end portion 821 where the four contacts shown are V+, V−, Vw, andVe signals in accordance with one embodiment in place of the workingelectrode 811, a guard trace 812, a reference electrode 813, and acounter electrode 814, respectively. In this manner, in one embodimentof the present disclosure, these signals of the active analyte sensor820 are low impedance and thus less subject to noise than the passivesensor signals. Moreover, in one embodiment, the analyte sensor 820configuration may include a flex circuit.

Referring now to FIG. 8C, in a further embodiment, an active sensor ofsimilar construction to the active sensor 820 of FIG. 11B but with muchsmaller dimensions is shown. More specifically, analyte sensor 830 isprovided with four contacts configured for direct wire bonding ratherthan a mechanical contact system as indicated by the large contact areason the previous two sensor configurations shown in FIGS. 8A-8B. Sincethe shape of the analyte sensor 830 is reduced, the sensor 830 may bewrapped around the cannula (for example, cannula 470 of FIG. 4) and thusonly a single entry site may be required for the patient analytemonitoring and insulin infusion. Moreover, within the scope of thepresent disclosure, additional sensor/cannula configurations may beprovided where the sensor circuitry and cannula are created as a singleassembly such as a cannula with the circuit 831 fabricated on thesurface.

FIG. 9 illustrates an integrated infusion device and analyte monitoringsystem with the infusion device and the monitoring system transmitterintegrated into a single patch worn by the patient in accordance withone embodiment of the present disclosure. Referring to FIG. 9, theintegrated infusion device and analyte monitoring system 900 includes anintegrated patch pump and transmitter unit 910 provided on an adhesivelayer 960, and which is configured to be placed on the skin of thepatient, so as to securely position cannula 950 and analyte sensor 940subcutaneously under the skin of the patient. The housing of theintegrated infusion pump and transmitter unit 910 is configured in oneembodiment to include the infusion mechanism to deliver medication suchas insulin to the patient via the cannula 950.

In addition, the integrated patch pump and transmitter unit 910 isconfigured transmit signals associated with the detected analyte levelsmeasured by the analyte sensor 940, over a wireless communication path930 such as an RF link. The signals are transmitted from the on bodyintegrated patch pump and transmitter unit 910 to a controller unit 920which is configured to control the operation of the integrated patchpump and transmitter unit 910, as well as to receive the transmittedsignals from the integrated patch pump and transmitter unit 910 whichcorrespond to the detected analyte levels of the patient.

Referring back to FIG. 9, in one embodiment the infusion mechanism ofthe integrated patch pump and transmitter unit 910 may include theinfusion device of the type described in U.S. Pat. No. 6,916,159assigned to the assignee of the present disclosure Abbott Diabetes Care,Inc. In addition, while a wireless communication over the communicationpath 930 is shown in FIG. 9, the wireless communication path 930 may bereplaced by a set of wires to provide a wired connection to shecontroller unit 920.

In this manner, in one embodiment of the present disclosure, theintegrated infusion device and analyte monitoring system 900 does notuse an infusion tubing which may provide additional comfort andconvenience to the patient by providing additional freedom from havingto wear a cumbersome tubing.

FIG. 10 is a detailed view of the infusion device cannula integratedwith analyte monitoring system sensor electrodes in accordance with oneembodiment of the present disclosure. Referring to FIG. 10, there isshown an infusion device cannula with analyte sensor electrodes 1020disposed therein, and mounted to an adhesive patch 1010 so as to retainits position securely in the patient. More specifically, as can be seenfrom FIG. 10, the cannula with analyte sensor electrodes 1020 includesensor electrodes 1021, 1022, 1023 (which may correspond to working,reference and counter electrodes, respectively) each of which areprovided within the cannula tip 1020, and further, positioned so as tomaintain fluid contact with the patient's analyte. In one aspect, someor all of the electrodes of the analyte sensor may be wrapped around thecannula, stacked on one or more inner and/or outer surfaces of thecannula.

FIG. 12A-12C each illustrate a cross sectional view of the infusiondevice cannula integrated with continuous analyte monitoring systemsensor electrodes of FIG. 10 in accordance with the various embodimentsrespectively, of the present disclosure. Referring to FIG. 12A, in oneembodiment, the wire and tubing are provided in parallel such that thetubing wall 1020, the tube bore for insulin flow 1024, the wire outercasing 1020 and the individual insulated wires 1021, 1022, 1023 aresubstantially provided as shown in FIG. 12A. More specifically, it canbe seen from the Figure that each of the three insulated wires areprovided with an insulation layer 1020 of tubing wall individuallysurrounding each insulated wire 1021, 1022, 1023, and further, where thethree insulated wires 1021, 1022, 1023 are in turn surrounded by thetubing wall 1020.

Referring now to FIG. 12B in one embodiment of the present disclosure,the insulated wires 1021, 1022, 1023 respectively connected to thesensor electrodes are co-extruded into tubing wall 1020, with the tubebore 1024 for insulin delivery and the insulated wires 1021, 1022, 1023configured substantially as shown in the FIG 12B. Referring now to FIG.12C, in still a further embodiment of the present disclosure, each ofthe insulated wires 1021, 1022, 1023 are wrapped around the tubing 1020and covered with a sheath 1210, thus providing the tubing wall 1020, thetubing bore 1024 for insulin delivery, the individual insulated wires1021, 1022, 1023, and the outer protective sheath 1210, which may alsoserve as an electromagnetic shield to eliminate electronic noise assubstantially shown is the Figure.

Referring again to the Figures, the embodiments shown in FIGS. 12A and12C may have a larger cross-sectional area (thus a larger hole needed tobe punctured on the skin of the patient), but are likely easier tomanufacture, more reliable and easier to make connection to the analytesensor electronics). Additionally, within the scope of the presentdisclosure, an optical data transmission (i.e. fiber optics) alonginsulin delivery tubing between sensor and pump may be provided insteadof integral wires as discussed above.

FIG. 11A illustrates a component perspective view of the infusion devicecannula integrated with analyte monitoring system sensor electrodes inaccordance with another embodiment of the present disclosure, while FIG.11B illustrates a top planar view of the analyte monitoring systemtransmitter unit integrated with infusion device in accordance with oneembodiment of the present disclosure. Referring to FIGS. 11A-11B, in oneembodiment of the present disclosure, integrated analyte sensor andinfusion device cannula 1100 comprise five laminated layers including atop insulation layer 1101, a conductive layer 1102 with electrode tracesdisposed thereon, followed by three layer substrate with integratedinfusion cannula 1103.

In one embodiment, the three layer substrate with integrated infusioncannula 1103 includes a separation/insulation layer 1103A to insulatethe sensor electrodes from the infusion cannula, a channel layer 1103Bconfigured to guide the flow of the insulin or any other suitablemedication, and an inlet/outlet layer 1103C. Also shown in FIG. 11A isan assembled view of the integrated analyte sensor and infusion devicecannula 1100.

Referring now to FIG. 11B, it can be seen that a patch pump as shown inone embodiment is provided with a transmitter unit 1110 and an insulinpump 1130 coupled to insulin reservoir 1120, and operatively coupled ormounted to the transmitter unit 1110. Also shown in FIG. 11B is theanalyte sensor contacts 1140 which are configured to establishelectrical contact with the respective electrodes of the integratedinfusion cannula and analyte sensor 1100. Also shown in FIG. 11B isinsulin port 1150 which is connected to the channel layer 1103B of theintegrated infusion device cannula and analyte sensor 1100.

In this manner, in one embodiment of the present disclosure, the patchpump may be worn by the patient on skin and which includes the insulininfusion mechanism as well as the analyte sensor and transmitter unit.

FIG. 13 is a timing chart for illustrating the temporal spacing of bloodglucose measurement and insulin delivery by the integrated infusiondevice and monitoring system in one embodiment. More specifically,insulin pumps typically deliver insulin in a periodic manner with theperiod of delivery in the range of 2 to 3 minutes and the duration ofdelivery at each period being on the order of a few seconds or less. Theamount of insulin that is delivered each period may be varied dependingon the overall insulin delivery rate that is desired. The analyte datais collected continuously (as, for example, a continuous current ofglucose oxidation) but is typically reported to the user periodically.The analyte reporting period is typically 1 to 10 minutes and glucoseoxidation current needs to be collected for 10 to 30 seconds in order togenerate a reportable glucose value (to allow for filtering etc.).

Indeed, the integration of analyte monitoring and insulin delivery maynecessitate placement of an analyte sensor in close proximity to aninsulin infusion cannula on the body. Such close proximity engenders thepossibility of insulin delivery interfering with the analytemeasurements. For example, if insulin infusion should result in alocalized decrease in the glucose concentration in the area of the bodynear the infusion site, then glucose measurement in this area would notbe representative of the glucose concentration in the body as a whole.Accordingly, in one embodiment of the present disclosure, there isprovided a method for temporal spacing of blood glucose measurements andinsulin delivery to mitigate the possible interference between insulininfusion and glucose measurements.

In accordance with one embodiment, the temporal spacing of analytemeasurement and insulin delivery may include providing a large atemporal space from after insulin delivery and before taking an analytemeasurement. Since both analyte measurement and insulin delivery areperformed periodically, a maximum spacing in time may be achieved ifanalyte measurement substantially immediately precedes insulin delivery.During the time between insulin delivery and the subsequent glucosemeasurement, infused insulin has time to diffuse and be transported awayfrom the infusion site due to normal circulation of interstitial fluid.An example timeline of temporally spaced analyte measurement and insulindelivery is shown in FIG 13. If multiple analyte measurements are takenbetween insulin delivery points, there should always be a reading justprior to insulin delivery and as well just after insulin delivery tominimize the affect of injected insulin on the glucose measurementreadings.

Although readings are typically taken periodically for simplicity inprocessing, a reading may be taken out of time with other readings andsealed appropriately for the overall reading average. Similarly, theinsulin delivery point may be delayed slightly until after the readingwith little or no affect as the readings typically occur much morefrequently than the infusions, which are intended to act over longerperiods of time. In addition, other timing considerations may beconsidered depending on the environment in which the integrated infusiondevice and analyte monitoring system is used by the patient, within thescope of the present disclosure to minimize potential error on measuredanalyte levels and/or introduce noise or potential adverse effects tothe infusion rates of the infusion device.

More specifically, fluctuation in the power supplies of the infusiondevice and/or the analyte monitoring system including, for example,batteries or related power distribution circuitry may introduceelectrical noise effects which may adversely affect the measuredreadings associated with the analyte monitoring system. For example,when the analyte monitoring system is configured to be in an activestate so as to be transmitting or receiving data, or when the pump cycleof the infusion device is active, the power supply may be affected bythe load from the data transmission/reception, or the pumping cycle. Theadverse effect of the power supply in addition to noise from othercomponents of the electronic circuitry may introduce undesirable noiseand adversely affect the accuracy of the analyte sensor measurements.

Accordingly, the transmitter unit 150 (FIG. 1) for example, may beconfigured to monitor the timing or occurrence of the measured analytelevel received from the analyte sensor 160 and the data transmissiontiming of the transmitter unit 150 such that the two events do notsubstantially overlap or occur at substantially the same time.Alternatively, the analyte monitor unit 120 (FIG. 1) may be configuredto compare the timing of the analyte sensor 160 measurement and thetiming of the data transmission from the transmitter unit 150, and todiscard data analyte related data received from the transmitter unit 150which coincide with the timing of the analyte measurements by theanalyte sensor 160.

Moreover in one embodiment, air bubble detection in the insulin tubingmay be provided, by monitoring fluid motion that would also detect theabsence of fluid such as that due to an air bubble in the line. In oneembodiment, the flow sensor may be configured to generate zero currentwhen an air bubble is present.

In addition, colorization of insulin may be provided for air bubbledetection in the tubing. Since pharmaceutical insulin is a clearcolorless liquid, it is difficult to visually discriminate betweeninsulin and air in tubing that carries insulin from the insulin pump tothe cannula. By providing a color tint to the insulin it would be mucheasier to visually identify air bubbles in the tubing and be able toremove them before they cause problems. An insulin tint in oneembodiment is biocompatible and insulin compatible.

In certain embodiments, the various components of the integrated system,for example, of the infusion device and analyte monitoring system 100(FIG. 1) may need periodic replacement, where the components may requirereplacement at different times during the usage of the integratedsystem. For example, the infusion device cannula may require replacementafter about each 3-days of usage, while the analyte sensor for use inthe analyte monitoring system may not require replacement until at leastabout five or seven days of usage. Accordingly, in one embodiment, thecomponents of the integrated system may be provided as replaceablemodular components such that one or more components may be replaced atdifferent times during the usage of the integrated system withoutsubstantially impacting the remaining portion of the integrated system.

More particularly, FIGS. 14A-14C illustrate modular combination ofmedication delivery and physiological condition monitoring system inaccordance with one embodiment. Referring to FIGS. 14A-14C, an on-bodypatch pump housing 1401 may be provided on the skin surface 1404 of thepatient, such that the cannula 1402 is positioned transcutaneouslythrough the patient's skin surface 1404 into the patient's body. Furthershown is a connection port 1403 provided on the housing 1401 of thepatch pump. As discussed in further detail below, the connection port1403 in one embodiment may be configured to couple to an end cap 1405(FIG. 14B) if the patch pump is used as a pump alone, or alternativelymay be configured to couple to an analyte sensor connector portion 1406when used as an integrated system with an analyte monitoring system.

Referring to the Figures, as can be seen, the analyte sensor may includea connector portion 1406 which is configured to couple to the connectionport 1403 of the patch pump housing to establish a substantially watertight seal, an anchor portion 1407 which is configured to securelyposition the analyte sensor on the skin surface 1404 of the patient, andthe tip portion 1408 which is trancutaneously positioned through theskin surface 1404 of the patient so as to be in fluid contact with thepatient's analyte.

In this manner, in one embodiment, the analyte sensor may be provided asa modular component which may be used in conjunction with the patch pumpas an integrated system. Alternatively, as discussed above, the patientmay select to use the patch pump alone without the continuous monitoringaspect of the integrated system. In this case, the modular systemdescribed herein may be easily used as a stand alone pump, where the endcap may be configured to provide a substantially water tight seal to thehousing 1401 of the patch pump.

Alternatively, the patch pump may be used in conjunction with theanalyte monitoring system wherein the patch pump housing 1401 may beconfigured to couple to the sensor connector portion 1406, establishingelectrical contact between the sensor electrodes to the respectiveinternal electronic components within the patch pump housing 1401. Inthis case, the electronic components associated with the analytemonitoring system, including the transmitter unit, processing unit andother components of analyte monitoring system may be providedsubstantially within the housing of the patch pump 1401.

In this manner, in certain aspects of the present disclosure, theintegrated system may be used as a stand along infusion device, thepatch pump and the analyte sensor may be replaced or changed independentof each other, and without substantially increasing the profile or theon-body size of the overall system, the sensor may be inserted orpositioned in the patient independent of the patch pump, and alsoremoved independent of the pump housing 1401.

FIGS. 15A-15C illustrates modular combination of medication delivery andphysiological condition monitoring system in accordance with anotherembodiment. Referring to the Figures, similar to the embodiment shown inFIGS. 14A-14C, the integrated system is provided with a patch pumphousing 1501 which is configured for positioning on the skin surface1504 of the patient, and which is operatively coupled to atranscutaneously positioned cannula 1502 for medication delivery to thepatient.

In the embodiment shown in FIGS. 15A-15C, the connection port 1503 ofthe patch pump is provided substantially on the top surface of the pumphousing 1501, such that, when desired, the analyte sensor connectorportion 1506 may be coupled to the patch pump via the connection port1503 from the top surface of the patch pump. Alternatively, as shown inFIG. 15B, in one aspect, a cap or a plug 1505 may be provided to seal(for example, water tight seal) the connection port 1503 when the patchpump housing 1501 is not connected to an analyte sensor, and thus foruse as a stand alone infusion device. In one aspect, the cap or plug1505 may include any suitable configuration, preferably to include a lowprofile physical dimension so as to maintain the low profileconfiguration of the on-body patch pump housing 1501.

As before, in particular embodiments, the connection port 1503 isconfigured to establish electrical connect with the various electrodesof the analyte sensor while providing a water tight seal at theconnection. Referring again to the Figures, the analyte sensor includesan anchor potion 1507 configured to securely position the sensor on theskin surface 1504 of the patient, and a tip portion 1508 which isconfigured for transcutaneous placement for fluid contact with thepatient's analyte.

While the embodiments described above include connection port of thepatch pump housing provided on an end surface or a top surface of thepump housing, within the scope of the present disclosure, the connectionport of the patch pump may be provided on any location of the patch pumphousing. For example, within the scope of the present disclosure, theconnection port providing a water tight seal when connected with an endcap (to establish closure), or with an analyte sensor (to use the patchpump in an integrated system with analyte monitoring), may be providedon the bottom, side, or any other surface of the patch pump housing.

FIG. 16 illustrates a top planar view of a modular sensor component inaccordance with one embodiment. More particularly, FIG. 16 illustratesthe analyte sensor of FIGS. 14A-14C or 15A-15C in one embodiment. Asshown, the connector portion 1506 of the analyte sensor is providedsubstantially on one end of the analyte sensor, while the sensingportion 1508 (for transcutaneous placement) of the analyte sensor isprovided substantially on the other end of the sensor. Also shown inFIG. 16 is the anchor portion 1507 which in one embodiment is configuredwith a relatively larger width compared to other portions of the sensor.

In this manner, the anchor portion 1507 may be configured tosubstantially securely retain the analyte sensor on the skin surface ofpatient. Furthermore, one or more of the patch pump housing and theanalyte sensor may be provided with an adhesive layer on the bottomsurface to secure positioning on the patient's skin surface duringusage. In a further aspect, the analyte sensor may comprise a flexcircuit so as to provide a low profile when worn on the body of thepatient.

FIG. 17 illustrates modular combination of medication delivery andphysiological condition monitoring system in accordance with yet anotherembodiment. Referring to FIG. 17, the patch pump 1701 is provided with aconnection port 1703 and positioned on the patient's skirt surface 1704so as to securely retain the transcutaneously positioned cannula 1702 atthe desired depth under the skin layer of the patient. Also shown in theFigure is a connection device 1706 which in one embodiment is providedwith a pump connector 1705 and a sensor connector 1707. Morespecifically, in one embodiment, a separate modular component isprovided and secured on the skin surface 1704 of the patient, and may beconfigured to connect to both the patch pump 1701 as well as the analytesensor. Moreover, within the scope of the present disclosure, theconnection device 1706 may be configured to further couple to othercomponents or devices as may be desired.

Referring back to FIG. 17, in one aspect, the connection device 1706 isconfigured to establish electrical connection between the sensor and thepatch pump such that the detected analyte levels from the tip portion1710 of the analyte sensor is received by the suitable electroniccontrol circuitry within the patch pump housing 1701. In an alternateembodiment, the analyte monitoring associated electronic components suchas data processing units, transmitter units, and the like, may beprovided within the connection device 1706. In this case, the patch pumphousing 1701 may be further optimized in size.

Referring yet again to FIG. 17, the connection device 1706 is configuredin one embodiment to include the pump connector 1705 which, in oneembodiment is configured to couple to the connection port 1703 of thepump to establish electrical contact and a substantially water tightseal. Furthermore the connection device 1706 may be further configuredto include a sensor connector portion 1707 which is configured toreceive or connect to the connector portion 1708 of the sensor so as toestablish electrical contact with the various electrodes of the sensor.That is, in one embodiment, the connector portion 1707 of the connectiondevice 1706 may be configured to couple to the sensor connector portion1708. Accordingly, when the sensor tip 1710 is inserted through the skinsurface 1704 of the patient and in fluid contact with the patient'sanalytes, and retained securely in place by the adhesive tab potion1709, the sensor connection portion 1708 is configured in one embodimentto establish electrical contact with the connection device 1706 totransfer or otherwise relay the signal level information associated withthe detected analyte levels of the patient for further processing.

In this manner, in one aspect of the present disclosure, there areprovided modular components or devices which comprise an integratedmedication delivery and analyte monitoring system, where each componentmay be independently replace, removed, or used on its own, and further,where the modular components may be used together as an integratedsystem for medication delivery and analyte monitoring.

Accordingly, a modular system for providing integrated medicationdelivery and physiological condition monitoring in one aspect includes afirst modular component configured for medication delivery, and a secondmodular component configured to analyte level detection, where thesecond modular component is connectable to the first modular componentto establish electrical contact with the first modular component, wherea substantially water tight seal is formed when the first and secondmodular component are connected, and further where one of the firstmodular component and the second modular component is configured forreplacement independent of the other component, and a third modularcomponent connectable to the first modular component when the firstmodular component is disconnected with the second modular component.

In one aspect, the first modular component may include a connection portfor coupling to either one of the second modular component or the thirdmodular component.

The first modular component may include a low profile infusion device.

The second modular component may include an analyte sensor.

Further, in one aspect, a water tight seal may be formed when the firstand third modular components are connected.

The first modular component in still another aspect may be configured todeliver medication to a patient at a first location in the patient, andfurther, wherein the second modular component is configured to detectanalyte level of the patient at a second location in the patient, wherethe first and second locations may be separated by a predetermineddistance, for example, approximately 12 inches.

The first modular component in another aspect may include a reusableportion and a disposable portion, where either of the second or thirdmodular components is connectable to the reusable portion of the firstmodular component.

The disposable portion of the first modular component may include one ormore of an infusion set, or a reservoir containing the medication fordelivery.

The reusable portion of the first modular component may include aprocessing unit to control the operation of one or more of the firstmodular component or the second modular component.

In yet still another aspect, the system may include a communication unitdisposed in one or more of the first modular component or the secondmodular component, the communication unit configured to transmit to orreceive data from a remote location.

The remote location may include one or more of a portable control unit,a computer terminal, a server terminal, a mobile telephone, or apersonal digital assistant.

The communication unit may be configured to transmit one or more signalscorresponding to a respective one or more analyte levels to the remotelocation.

In another aspect, the communication unit may be configured to receive aflow instruction command to control delivery of the medication.

Further, in still another aspect, the communication unit may beconfigured to wirelessly communicate over one or more of an Rfcommunication link, a Bluetooth communication link, or an infraredcommunication link.

The second modular component in a further aspect may include an innerwall and an outer wall, a plurality of electrodes disposed between theinner wall and the outer wall, and a fluid delivery channel formed bythe inner wall, where the plurality of electrodes may include an analytesensor.

A method in accordance with another embodiment may include providing afirst modular component for medication delivery, providing a secondmodular component configured to analyte level detection, the secondmodular component connectable to the first modular component toestablish electrical contact with the first modular component, forming asubstantially water tight seal when the first and second modularcomponents are connected, and providing a third modular componentconnectable to the first modular component when the first modularcomponent is disconnected with the second modular component, where oneof the first modular component and the second modular components areconfigured for replacement independent of the other component.

In another aspect, the method may include delivering medication to apatient, and monitoring analyte level of the patient substantiallyconcurrently to the medication delivery.

A modular system for providing integrated medication delivery andphysiological condition monitoring in accordance with still anotheraspect includes a replaceable first modular component configured todeliver medication, a replaceable second modular component configured toanalyte level detection, where the second modular component isconnectable to the first modular component to establish electricalcontact with the first modular component, and a third modular componentconnectable to the first modular component when the first modularcomponent is disconnected from the second modular component, where asubstantially water tight seal is formed when the first and secondmodular components are connected or when the first and third modularcomponents are connected.

The one of the first modular component and the second modular componentsmay be configured for replacement independent of the other component.

The first modular component may include a connection port to couple toeither one of the second modular component or the third modularcomponent, and further, where the third modular component may include acap configured to couple to the connection port of the first modularcomponent.

The cap may include an end cap or a plug.

The analyte level monitored may include glucose level.

The first modular component may include a low profile infusion device.

The second modular component may include an analyte sensor.

The first modular component may be configured to deliver medication to apatient at a first location in the patient, and further, where thesecond modular component may be configured to detect analyte level ofthe patient at a second location in the patient.

In yet a further aspect, the first and second locations are separated bya predetermined distance.

The first modular component may include a reusable portion and adisposable portion, where either of the second or third modularcomponents are connectable to the reusable portion of the first modularcomponent.

The disposable portion of the first modular component may include one ormore of an infusion set, or a reservoir containing the medication fordelivery.

The reusable portion of the first modular component may include aprocessing unit to control the operation of one of more of the firstmodular component or the second modular component.

Also the system may include a communication unit disposed in one or moreof the first modular component or the second modular component, thecommunication unit configured to transmit to or receive data from aremote location, an further, where the remote location may include oneof more of a portable control unit, a computer terminal, a serverterminal, a mobile telephone, or a personal digital assistant.

The communication unit may be configured to transmit one or more signalscorresponding to a respective one or more analyte levels to the remotelocation.

Also, the communication unit may be configured to receive a flowinstruction command to control delivery of the medication.

The communication unit may be configured to wirelessly communicate overone or more of an RF communication link, a Bluetooth communication link,or an infrared communication link.

In still yet another aspect, the second modular component may include aninner wall and an outer wall, a plurality of electrodes disposed betweenthe inner wall and the outer wall, and a fluid delivery channel formedby the inner wall.

The plurality of electrodes may comprise an analyte sensor.

A method in accordance with another aspect includes positioning areplaceable first modular component on a skin surface of a user,connecting a replaceable second modular component to a predeterminedlocation on the first modular component during a first time period,wherein a water tight seal is formed between the first modular componentand the second modular component, and connecting a third modularcomponent to the predetermined location first modular component during asecond time period, where a water tight seal is formed between the firstmodular component and the second modular component, and further wherethe first time period and the second time period are nonoverlapping.

The method may include delivering medication to the user, and monitoringanalyte level of the user.

A kit in still another aspect may include an infusion device configuredto deliver medication, the infusion device including a port, an analytemonitoring device configured to monitor an analyte level of a user, theanalyte monitoring device connectable to the port of the infusion deviceduring a first predetermined time period, and a cap connectable to theport of the infusion device during a second predetermined time period,where the first and second predetermined time periods arenonoverlapping.

The infusion device may include an on-body patch pump.

The cap provides a water tight seal on the port when connected to theinfusion device.

The analyte monitoring device provides a water tight seal on the portwhen connected to the infusion device.

In still yet a further aspect, a system including an infusion device andan analyte monitoring unit includes an infusion device, an on-body unitincluding a data transmission section, the on-body unit further coupledto the infusion device, the on-body unit configured to receive one ormore signals corresponding to a respective one or more analyte levels,and further, the on-body unit configured to infuse a fluid received fromthe infusion device, and a receiver unit operatively coupled to theon-body unit the receiver unit configured to receive data from theon-body unit, wherein the received data is associated with the analytelevel.

The system may further include an analyte sensor at least a firstportion of which is in fluid contact with an analyte of a patient, andfurther, where at a second portion of the analyte sensor is in signalcommunication with the data transmission section.

The data transmission section may in one embodiment be configured totransmit the one or more signals corresponding to a respective one ormore analyte levels substantially periodically at one or morepredetermined time intervals, where the one of more predetermined timeintervals may include one or more of approximately 30 seconds,approximately one minute, or approximately 90 seconds.

In one aspect, the on-body unit may include a cannula at least a portionof which is subcutaneously positioned under a skin layer, and further,may also include an infusion tubing connected to the infusion device todeliver the fluid to the on-body unit. The infusion tubing and theon-body unit in a further aspect may be connected in a substantiallywater tight seal.

In yet another embodiment, the infusion tubing may be configured tooperatively couple to the cannula to deliver the fluid.

The on-body unit may be configured to wirelessly transmit the one ormore signals corresponding to the respective one or more analyte levelsto the receiver unit, where the on-body unit and the receiver may beconfigured to wirelessly communicate over one or more of an RFcommunication link, a Bluetooth communication link, or an infraredcommunication link.

In addition, the infusion device in a further embodiment may beconfigured to control the delivery rate of the fluid based on the one ormore signals corresponding to the respective one or more analyte levelsreceived by the receiver unit, and further, where the infusion devicemay be configured to determine a modified deliver protocol fordelivering fluid such as insulin based on information associated withthe one or more signals corresponding to the respective one or moreanalyte levels.

In yet another aspect, the modified delivery protocol may include one ormore of a correction bolus, a modified basal profile, a carbohydratebolus, and extended bolus, or combinations thereof.

The receiver unit in one embodiment may be configured to wirelesslycommunicate with the infusion device.

In a further embodiment, the receiver unit may be integrated into ahousing of the infusion device.

A method of integrating analyte monitoring and fluid infusion in anotherembodiment of the present disclosure includes infusing a fluid at apredetermined delivery rate, detecting one or more unable levels,transmitting one or more signals associated with the respective detectedone or more analyte levels, and determining a modified delivery ratebased on the transmitted one or more signals.

In one aspect, the one or more signals may be transmitted substantiallyimmediately after the associated respective one or more analyte levelsare detected.

Moreover, the transmitting step in one embodiment may include wirelesslytransmitting the one or more signals which wirelessly transmitted overone or more of an RF communication link, a Bluetooth communication link,an infrared communication link, or combinations thereof.

The method in a further aspect may also include the steps of receivingthe transmitted one or more signals, and displaying the received one ormore signals.

Moreover, the method may also include the step of displaying themodified delivery rate. In addition, the method may also include thestep of implementing the modified delivery rate, where the predetermineddelivery rate may include one or more basal delivery rates.

The modified delivery rate in a further embodiment may include one ormore of a correction bolus, a modified basal profile, a carbohydratebolus, an extended bolus, or combinations thereof.

An apparatus including an analyte sensor and a fluid delivery channel inyet another embodiment of the present disclosure includes a fluiddelivery unit having an inner wall and an outer wall, and a plurality ofelectrodes disposed between the inner wall and the outer wall of thefluid delivery unit, where a portion of the fluid delivery unit and aportion of the plurality of electrodes are subcutaneously positionedunder a skin layer.

In nee aspect, the plurality of electrodes may comprise an analytesensor, including, for example, one or more of a working electrode, acounter electrode, a reference electrode, or combinations thereof.

The fluid delivery unit may include a channel for delivering a fluidsuch as insulin, the channel substantially formed by the inner wall.

An apparatus including an analyte sensor and a fluid delivery channel inaccordance with still another embodiment of the present disclosureincludes a first tubing having a first tubing channel, and a secondtubing having a second tubing channel including a plurality ofelectrodes disposed within the second tubing channel, where at least aportion of the first tubing and at least a portion of the second tubingare subcutaneously positioned under a skin layer.

In one embodiment, the plurality of the electrodes may be substantiallyand entirely insulated from each other.

In another embodiment the first tubing and the second tubing may beintegrally formal such that an outer surface of the first tubing issubstantially in contact with an outer surface of the second tubing.

A system including an infusion device and an analyte monitoring unit inaccordance with still another embodiment of the present disclosureincludes an infusion and monitoring device, an on-body unit including adata transmission section, the on-body unit further coupled to theinfusion and monitoring device, the on-body unit configured to receiveone or more signals corresponding to a respective one or more analytelevels, and further, the on-body unit configured to infuse a fluidreceived from the infusion and monitoring device, and a connectorcoupled at a first end to the infusion device, and further, coupled at asecond end to the on-body unit, the connector configured to channel thefluid from the infusion device to the on-body unit, and further,configured to provide the one or more signals corresponding to therespective one or more analyte levels to the infusion and monitoringdevice.

In one aspect, the infusion and monitoring device may be configured toexecute fluid delivery to a patient, and further, to detect analytelevels of the patient over a predetermined time period.

In a further aspect, the infusion and monitoring device may include acontnuous glucose monitoring system.

In still another aspect, the infusion and monitoring device may includean insulin pump.

A method of fluid delivery and analyte monitoring in accordance withstill another embodiment of the present disclosure includes determininga delivery profile for fluid infusion, wherein the delivery profileincluding a plurality of predetermined discrete fluid infusion eachtemporally separated by a predetermined time period, and sampling ananalyte level substantially immediately prior to each predetermineddiscrete fluid infusion.

The method may further include the step of sampling an analyte levelsubstantially immediately after each predetermined discrete fluidinfusion.

All references cited above herein, in addition to the background andsummary sections, are hereby incorporated by reference into the detaileddescription of the preferred embodiments as disclosing alternativeembodiments and components.

Various other modifications and alternations in the structure and methodof operation of the invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments.

What is claimed is:
 1. A method, comprising: positioning a replaceablefirst modular component on a skin surface of a user; connecting areplaceable second modular component to a predetermined location on thefirst modular component during a first time period, wherein a watertight seal is formed between the first modular component and the secondmodular component; connecting a third modular component to thepredetermined location first modular component during a second timeperiod, wherein a water tight seal is formed between the first modularcomponent and the third modular component; wherein the first time periodand the second time period are nonoverlapping.
 2. The method of claim 1including: delivering medication to the user; and monitoring analytelevel of the user.
 3. The method of claim 1 wherein the analyte includesglucose.
 4. A kit, comprising: an infusion device configured to delivermedication, the infusion device including a port; an analyte monitoringdevice configured to monitor an analyte level of a user, the analytemonitoring device connectable to the port of the infusion device duringa first predetermined time period; a cap connectable to the port of theinfusion device during a second predetermined time period; wherein thefirst and second predetermined time periods are overlapping.
 5. The kitof claim 4 wherein the analyte includes glucose.
 6. The kit of claim 4wherein the infusion device includes an on-body patch pump.
 7. The kitof claim 4 wherein the cap provides a water tight seal on the port whenconnected to the infusion device.
 8. The kit of claim 4 wherein theanalyte monitoring device provides a water tight seal on the port whenconnected to the infusion device.